Life Sciences 3Q/2024

New Indirect Consumption Tax

Starting January 2025, Slovakia will introduce a new tax on sugary soft drinks under a newly passed law. The primary goal is to reduce the consumption of sweetened beverages while also boosting state budget revenues.

The tax will apply to packaged non-alcoholic drinks containing added sugar, sweeteners, or sweet ingredients.

This will be an indirect consumption tax, targeting manufacturers and distributors who bring these beverages to the Slovak market for the first time. While it won’t directly affect consumers, it’s expected to be reflected in the final price of the drinks.

The tax rates will vary depending on the type of sugary drink, ranging from € 0.15 per liter to € 1.05 per liter.

For more information:

New Indirect Consuption Tax

AI against the antibiotic resistance

The discovery of drugs that can destroy bacteria has historically been either a matter of chance or years of intense research. Now, a new path is emerging using artificial intelligence (AI). According to the World Health Organization (WHO), antibiotic resistance poses one of the greatest threats to humanity, potentially pushing medicine back by a century.

Without new solutions, routine procedures such as minor surgeries and childbirth could become deadly once again. AI is now being used by researchers to study global microbiomes in search of new antibiotic compounds.

A research team from the University of Pennsylvania has used AI to identify nearly one million new bacterial cells that could replace current antibiotics. By utilizing machine learning, they screened genetic data to predict molecules with antimicrobial properties, creating and testing synthetic molecules in the lab.

This innovative approach has led to the discovery of promising candidates, some with comparable efficiency to existing antibiotics, offering new hope in the fight against antibiotic-resistant bacteria.

For more information:

AI against the antibiotic resistance

Expanding the Competence of Nurses and Midwives

Effective July 30, 2024, Decree No. 95/2018 Coll. has been amended to broaden the scope of responsibilities for nurses and midwives, depending on their level of education.

The goal of this amendment is to grant nurses and midwives greater autonomy by allowing them to perform a wider range of tasks independently. This change will improve patient access to healthcare and elevate the status of these professions.

Under the new rules, nurses and midwives can now independently triage patients based on the urgency of their condition, administer a broader range of medications, and take on expanded roles in newborn care and conducting basic allergy skin tests. Nurses will still present the test results to doctors for evaluation.

This decree will provide a clear and comprehensive overview of the expanded competencies for nurses and midwives.

For more information:

Expanding the Competence of Nurses and Midwives

EU Takes Action Over Late Payments by Public Healthcare Institutions in Slovakia

The C-412/23 case involves the European Commission filing a violation action against Slovakia.

The core issue revolves around delayed payments by public healthcare institutions in Slovakia. Specifically, the European Commission claims that Slovakia violated its obligations under EU law by failing to ensure that its public healthcare institutions comply with the 60-day payment deadline set out in Article 4 (4) (b) of Directive 2011/7/EU of the European Parliament and of the Council of 16 February 2011 on combating late payment in commercial transactions.

The aim of the above-mentioned Directive is to prevent financial imbalances and protect business interests in the internal market.

The Court of Justice of the European Union ruled in favour of the European Commission and found that Slovakia had violated EU law.

For more information:

EU Takes Action Over Late Payments by Public Healthcare Institutions in Slovakia

HHC to be added to the list of banned substances in Slovakia

The Ministry of Health recently announced on social media that psychotropic substances like HHC, HHC-P, and HHC-O – commonly found in vending machines – will no longer be sold as “legal alternatives” to cannabis starting November.

A recent report revealed that studies on HHC and its chemical cousins show worrying results. These substances have been linked to addiction, causing both psychological and physical dependency. The effects, much like those of THC, come with alarming behavioural changes and serious health risks.

The decisive move to ban these substances stems from a growing concern for children’s safety. The National Institute of Children’s Diseases flagged this threat as early as last year, and now action is being taken to safeguard the young.

With new dangerous substances constantly hitting the market, the ministry is planning legislative changes to speed up the process of adding these substances to the list of banned ones.

For more information:

HHC to be added to the list of banned substances in Slovakia

EMA and HMA Set Guidelines for Safe Use of LLMs

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released key recommendations for using large language models (LLMs) across European medicines regulatory network.

LLMs can streamline processes, such as data mining and querying documents, but they also come with risks like inaccuracies and data security concerns. The new guidelines emphasize the importance of understanding both the strengths and limitations of LLMs, promoting safe data handling, critical thinking, and cross-checking results.

Continuous training and governance will help regulatory staff adapt to the rapidly evolving AI landscape. These guidelines are part of a broader AI workplan guiding EMA’s digital transformation through 2028.

For more information:

EMA and HMA Set Guidelines for Safe Use of LLMs

The amendment to the National Health Information System Act

The proposed amendment aims to further digitalize healthcare services in Slovakia. It introduces electronic systems for managing lab test requests and results, reducing redundant testing and improving data accuracy.

A new centralized platform for booking patient appointments will also be created, alongside electronic agreements for general and specialized gynecological care.

The amendment ensures compliance with EU data protection laws while allowing secure sharing of health information for public health purposes. Additionally, it establishes a National Vaccination Registry and strengthens digital tools for public health investigations.

For more information:

The amendment to the National Health Information System Act

Pilot programme to support orphan medical devices

The European Medicines Agency (EMA) has introduced a new pilot programme to assist manufacturers and notified bodies in developing and evaluating orphan medical devices.

This initiative provides free expert panel advice on clinical evaluations and aims to establish a long-term support process by 2025. Orphan devices, designed for conditions affecting fewer than 12.000 people annually in the EU, address rare diseases with limited treatment options.

The programme prioritizes high-impact devices, including those for life-threatening conditions, children, and novel treatments. This effort aligns with new EU guidance on clinical evaluation, fostering innovation and improving patient access to vital medical devices.

For more information:

Pilot programme to support orphan medical devices

The European Health Data Space and new regulation

On April 24, 2024, the European Parliament adopted two significant initiatives aimed at strengthening the European Health Union:

• the European Health Data Space, and
• new rules for ensuring the safety and quality of human-origin substances in healthcare.

The European Health Data Space was further discussed in the first Market Report in an article titled ‘European Health Data Space (EHDS): Position of the Council and Parliament.’

The new regulation 2024/1938 of the European Parliament and the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC focuses on updating standards for the quality and safety of substances such as blood, tissues, and cells used in healthcare.

It aims to protect both recipients and donors, ensuring that substances like human breast milk and other new materials are also regulated. Additionally, the regulation strengthens cooperation between EU member states to ensure the safe handling and availability of these critical resources.

For more information:

The European Health Data Space and new regulation

AI Act and its impact on healthcare

The use of AI systems is nowadays common practice, and healthcare is no exception in using these systems.

To protect and secure against the effects of AI, the European Union has adopted the Artificial intelligence Act, which represents the most comprehensive legal regulation of AI in the world. We provide an overview of the aspects of the law that have an impact on the use of AI in healthcare.

The most important is that the AI Act defines as high-risk AI medicinal devices, emotion recognition based on medical or safety reasons.

For high-risk AI tools, the following important rules apply:

• Risk Management: AI providers must set up a system to find, assess, and reduce risks that could come from using the AI.
• High-Quality Data: High-risk AI must be trained on good-quality data to make sure it is accurate, reliable, and free from mistakes or bias.
• Technical Documentation: Detailed technical documents must be prepared before the AI is sold or used, and these documents should be kept up-to-date as the AI evolves.
• Event Logging: High-risk AI systems must be able to automatically record events (logs) while they are running. These logs should follow accepted standards so they can be easily reviewed.
• Transparency and Explainability: High-risk AI must be clear and understandable so that users, like healthcare staff, can easily monitor and oversee the system.
• Human Oversight: These systems must allow for human control. If the AI makes a mistake, a human should be able to step in and correct or reverse the decision.
• Accuracy, Strength, and Security: High-risk AI must be designed to be accurate, strong, and secure from the start and should continue working well and safely throughout its entire life cycle.

For more information:

AI Act and its impact on healthcare

Introducing legal framework for telemedicine

Currently, the evaluation of the interdepartmental review process for the proposed amendment to the Healthcare and Related Services Act and other acts, is underway, which will finally introduce the concept of telemedicine into the law. The amendment defines telemedicine as a form of healthcare delivery where care is provided through remote electronic communication.

The European Commission has defined telemedicine as the provision of healthcare in situations where the healthcare professional and the patient (or two professionals) are not in the same location.

A comment was submitted pointing out the incorrectness of the definition in the proposed amendment. It was suggested that the definition be expanded to include teleconsultation, which refers to remote communication using standardized communication technologies between a patient and a healthcare professional, between two or more healthcare professionals, or between a healthcare professional and a social worker.

For more information:

Introducing legal framework for telemedicine

Procedural Regulation for Joint Clinical Assessment

The regulation outlines procedural rules related to the joint clinical assessment (JCA) of technologies in the EU. This involves the preparation and updating of common clinical assessments for human-use medicinal products at the EU level.

Key points of the regulation include:

1. Framework and Cooperation: The regulation implements detailed procedures for cooperation among EU member states in assessing medical technologies, with coordination by the Coordination Group.
2. Interaction and Data Exchange: The document provides rules for interaction between various entities like the European Medicines Agency, the coordination group, subgroups, developers, patients, clinical experts, and other stakeholders during the JCA.
3. Patient and Expert Involvement: Special provisions are introduced for the involvement of patients, clinical experts, and other relevant experts during the JCA to ensure scientific rigor and to reflect clinical realities.
4. Procedural Timelines: Specific timelines for assessments are defined, especially aligning with the EMA’s centralized procedures for authorizing or modifying drug marketing authorizations.
5. Data Confidentiality: The regulation emphasizes confidentiality, especially regarding the protection of patient data and other sensitive commercial information of developers.
6. Document Formats: It also defines standard formats for the submission of documents, analyses, and clinical data needed for JCA.

The regulation establishes a transparent process for collaboration between EU entities and stakeholders in preparing and updating clinical assessments, ensuring consistency and high-quality scientific evaluation of medicines across EU member states.

For more information:

Procedural Regulation for Joint Clinical Assessment

Report on food safety and agri-food fraud investigations published by Commission

The Commission’s report reflects enhanced vigilance and cooperation among EU member states and external partners in relation to food safety and agri-food fraud investigations. The key hazards identified in 2023 were pesticide residues, pathogenic microorganisms, particularly salmonella, and mycotoxins in food products.

Food fraud remains a major concern, with a surge in cases involving fraudulent practices, especially in the meat, honey, and olive oil sectors. Common issues included ingredient substitution, mislabelling, and document forgery. Coordinated actions were launched to combat the illegal trade of pets and counterfeit plant protection products.

Emerging concerns in 2023 centred around fraudulent practices in dietetic foods and supplements, where unauthorized ingredients and misleading health claims were prevalent. Additionally, cases involving cannabinoids in food were flagged, as CBD remains unauthorized for use in food products within the EU.

Overall, the report underscores the growing cooperation within the EU and with non-EU countries to address food safety risks. There is an increasing focus on preventing fraud, particularly in labelling and ingredient substitution.

The Commission is investing in advanced IT and AI tools to enhance food safety monitoring and fraud detection. Protecting consumers from unauthorized substances and ensuring accurate labelling remain top priorities as the EU continues to improve its regulatory frameworks and enforcement efforts.

For more information:

Report on food safety and agri-food fraud investigations published by Commission

Drug Exception Policies Heads to Constitutional Court

The Bratislava Administrative Court has referred a case to the Constitutional Court of the Slovak Republic, challenging the legal framework for covering drugs by exception and its potential conflict with the Constitution. Specifically, the court argues that allowing health insurers to set their own criteria for deciding on drug exceptions violates Articles 40, 13(2), and 51 of the Constitution, as these criteria should be determined by law. It also raises concerns that arbitrary decisions by health insurers may contradict the principle of fair distribution of public resources and the right to equal access under equal conditions.

The court points out that health insurers currently have no limits in deciding on requests for drug exceptions and can set criteria to suit their own interests. Furthermore, the court believes that patients should have a legal entitlement to the reimbursement of drugs by exception. Under the current legal framework, insurers “may” approve a patient’s request, which could undermine the principle of legal certainty due to the lack of predictability in decision-making.

It is now up to the Constitutional Court to determine whether the law will be amended by introducing new limits and regulations for drug exceptions.

For more information:

Drug Exception Policies Heads to Constitutional Court